Can Product-Specific Assurance Case Templates Be Used as Medical Device Standards?

Wassyng, Alan; Singh, Neeraj Kumar; Geven, Mischa; Proscia, Nicholas V.; Wang, Hao; Lawford, Mark; Maibaum, Tom

doi:10.1109/mdat.2015.2462720

Cited by 20 publications

(11 citation statements)

References 11 publications

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“…There are several approaches to justifying confidence, such as eliminative induction [19], quantitative estimation [22], provided as claims in the assurance case [20]. Wassyng et al [43,42] propose an Assurance Case Template used in the development of critical systems and their certification within a domain model.…”

Section: Certification and Conformancementioning

confidence: 99%

Standard Conformance-by-Construction with Event-B

Mendil

Aït‐Ameur

Singh

et al. 2021

Formal Methods for Industrial Critical Systems

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Checking the conformance of a system design to a standard is a central activity in the system engineering life cycle, a fortiori when the concerned system is deemed critical. Standard conformance checking entails ensuring that a system or a model of a system faithfully meets the requirements of a specification of a standard improving the robustness and trustworthiness of the system model. In this paper, we present a formal framework based on the correct-by-construction Event-B method and related theories for formally checking the conformance of a formal system model to a formalised standard specification by construction. This framework facilitates the formalization of standard concepts and rules as an ontology, as well as the formalization of an engineering domain, using an Event-B theory consisting of data types and a collection of operators and properties. Conformance checking is accomplished by annotating the system model with typing conditions. We address an industrial case study borrowed from the aircraft cockpit engineering domain to demonstrate the feasibility and strengths of our approach. The ARINC 661 standard is formalised as an Event-B theory. This theory formally models and annotates the safety-critical real-world application of a weather radar system for certification purposes.

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Section: Certification and Conformancementioning

confidence: 99%

Standard Conformance-by-Construction with Event-B

Mendil

Aït‐Ameur

Singh

et al. 2021

Formal Methods for Industrial Critical Systems

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“…The authors of [19] provide a format, including meta-data, that allows to capture and reuse patterns. In the case of medical devices, the authors [40] explain all the advantages of using patterns in standards; and their arguments are valid in any application domain.…”

Section: Assurance Casesmentioning

confidence: 99%

Patterns for Certification Standards

Delmas

Pagetti

Polacsek

2020

Advanced Information Systems Engineering

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One of the absolute preconditions for a safety-critical system to enter the market is to be issued a certificate by the regulating authorities. To this end, the "applicant" must demonstrate the compliance of its product with the domain's standards. The high complexity of this process has led applicants to rely on assurance cases made for certification in the medical, nuclear, or aeronautic domains. In this paper, we propose a generic method that guides the applicant through the specification of assurance cases for a complex standard. Unlike existing works focused on a single context, our objective is to provide an approach that is both generic and domain-agnostic. In order to illustrate this new approach, we present the results of its application on a real-world case study, which pointed out new issues and led to improvements.

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“…As previously done for medical device assurance cases [50], we have divided the top goal into four sub-goals, as shown in Figure 5. The first sub-goal (GR) argues for the quality of the documentation of the requirements.…”

Section: Assurance Casementioning

confidence: 99%

“…Further evidence for the validity of applying assurance cases to SCS is the success they have found for real time safety critical systems [29,31,50]. From the perspective of assurance cases, SCS and real-time systems are not that different.…”

Section: Validation Of Assurance Case Approachmentioning

confidence: 99%

“…A potential solution to these problems is to have the SCS developers create, or partially create, an assurance case before, or while they develop their software. Assurance case techniques have been developed and successfully applied for real time safety critical systems [29,31,50]. An assurance case presents an organized and explicit argument for correctness (or whatever other software quality is deemed important) through a series of sub-arguments and evidence.…”

Section: Introductionmentioning

confidence: 99%

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Building Confidence in Scientific Computing Software Via Assurance Cases

Smith,

Nejad,

Wassyng

2019

Preprint

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Assurance cases provide an organized and explicit argument for correctness. They can dramatically improve the certification of Scientific Computing Software (SCS). Assurance cases have already been effectively used for safety cases for real time systems. Their advantages for SCS include engaging domain experts, producing only necessary documentation, and providing evidence that can be verified/replicated. This paper illustrates assurance cases for SCS through the correctness case for 3dfim+, an existing Medical Imaging Application (MIA) for analyzing activity in the brain. This example was partly chosen because of recent concerns about the validity of fMRI (Functional Magnetic Resonance Imaging) studies. The example justifies the value of assurance cases for SCS, since the existing documentation is shown to have ambiguities and omissions, such as an incompletely defined ranking function and missing details on the coordinate system. A serious concern for 3dfim+ is identified: running the software does not produce any warning about the necessity of using data that matches the parametric statistical model employed for the correlation calculations. Raising the bar for SCS in general, and MIA in particular, is both feasible and necessary when software impacts safety, an assurance case methodology (or an equivalently rigorous confidence building methodology) should be employed.

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Can Product-Specific Assurance Case Templates Be Used as Medical Device Standards?

Cited by 20 publications

References 11 publications

Standard Conformance-by-Construction with Event-B

Standard Conformance-by-Construction with Event-B

Patterns for Certification Standards

Building Confidence in Scientific Computing Software Via Assurance Cases

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